Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed Refractory Multiple Myeloma (RRMM)

In brief

The goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory/relapsed multiple myeloma.

Key facts

Study ID: NCT06645678
Run by: YOUNGIL KOH
People needed: 75
Starts: 2024-11-26
Expected to finish: 2027-10-01
Last updated by the study team: 2025-12-03

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must satisfy the following criteria to be enrolled in the study:
Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF).
② Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
④ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or B. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or C. For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
Patients with measurable disease and extramedullary disease will be allowed to participate if there is a measurable extramedullary lesion. These patients require PET-CT follow-up for response evaluation. Those with extramedullary disease (EMD) only will not be allowed to participate: i.e, Patients with plasmacytoma as the only measurable disease are not eligible. For the definition of EMD, refer to Section 8.1.3.
⑤ Subject has received 2 or more prior lines of antimyeloma therapy. (Note: One line can contain several phases [e.g., induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and/or (with or without) maintenance therapy).
⑥ Subject must have received at least one proteasome inhibitor and lenalidomide.
⑦ Subject achieved minimal response or better to at least 1 prior antimyeloma therapy.
Subject must have documented disease progression during or after their last antimyeloma regimen.
⑨ Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
⑩ Individual of childbearing potential (IOCBP) must: A. Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence* from heterosexual contact.
B. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting study treatment, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of mezigdomide or 150 days after the last dose of elranatamab, whichever is longer.
Note: A IOCBP (Individual of childbearing potential): an individual who: 1) has achieved menarche (first menstrual cycle) at some point; 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral salpingectomy (the surgical removal of the fallopian tubes) or oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (without an alternative medical cause eg, amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (ie, has had menses at any time during the preceding 12 consecutive months).
⑪ Male subjects must: A. Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant individual or an individual of childbearing potential while participating in the study, during dose interruptions and for at least 28 days after the last dose of mezigdomide whichever is longer, even if he has undergone a successful vasectomy.
True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
Male subjects must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 28 days following last dose of mezigdomide,
Females must agree to refrain from donating eggs while on study treatment and for at least 28 days after last dose of mezigdomide.
Subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of mezigdomide.
Subjects must agree to refrain from receiving live vaccines while on study treatment, during dose interruptions and for at least 90 days following the last dose of the study treatment.
Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment:
1 Subject who has had prior treatment with mezigdomide. 2 Patients with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may significantly alter the absorption of mezigdomide and/or other oral study intervention.
3 Subject who has had prior treatment with anti-BCMA agents (including CAR T-cell therapy, bispecifics and antibodies).
4 Subject who has had any investigational agents within 28 days or 5 half-lives (whichever is shorter) of initiating study treatment.
A. Participation in another interventional clinical trial concurrent with this study is not permitted, except for those who have completed treatment with the prior investigational agent(s) and are currently in Long-term Follow up.

Where it is running

Asan Medical Center, University of Ulsan College of Medicine — Seoul, South Korea (enrolling)
Singhealth Duke NUS blood cancer center — Singapore, Singapore (enrolling)
Chonnam National University Hwasun Hospital — Hwasun, South Korea (enrolling)
National University Hospital (NUH) — Singapore, Singapore (enrolling)
Samsung Medical Center, Sungkyunkwan University School of Medicine — Seoul, South Korea (enrolling)
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Seoul, South Korea (enrolling)
Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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